VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that its abstract highlighting additional biomarker data from the ongoing Phase 1/2a study of VBI-1901, the company's cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) patients was selected for an e-poster presentation at The European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Title: TCR and HLA analysis of patients in a Phase I/IIa trial of a therapeutic CMV vaccine against recurrent glioblastoma (GBM)
Abstract #: 4112
Date/Time: Thursday, September 17, 2020 – Monday, September 21, 2020
About the Phase 1/2a Study Design
VBI's two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:
- Phase 1 (Part A)
- Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
- This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
- Enrollment completed in December 2018.
- Phase 2a (Part B)
- Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
- This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK's proprietary AS01B adjuvant system as immunomodulatory adjuvants.
- Enrollment of the 10 patients in the GM-CSF arm is complete. Enrollment of the 10 patients in the AS01B arm is ongoing.
VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with the AS01B adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.